A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This study is an open-label, multi-center, dose-escalation, dose-finding and expansion study
in adult subjects with advanced solid tumors for whom no standard therapy is available. The
study will evaluate the safety, tolerability, PK, PD, and preliminary anti-tumor efficacy of
SM08502 administered orally, once daily, following a 28-day treatment cycle (Part 1A).
Alternative dosing schedules will be explored in Part 1B and the recommended Part 2 dose and
schedule will be further evaluated in Part 2.
Subjects will participate in a screening period of up to 14 days. Dosing in 28-day cycles
will continue within each subject, unless treatment is discontinued due to toxicity, disease
progression, initiation of a new anti-neoplastic therapy, withdrawal of consent, the Sponsor
terminates the study, or the subject no longer meets retreatment criteria.